Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes
- Registration Number
- NCT04523363
- Lead Sponsor
- Gianna Wilkie
- Brief Summary
The purpose of this study is to assess if metformin reduces adverse outcomes associated with prediabetes in pregnancy. Our hypothesis is that pregnant women with prediabetes who are treated with metformin will show a greater reduction in large for gestational age infants at birth compared to women treated with the standard of care.
- Detailed Description
Women in pregnancy are routinely screened for diabetes in the first trimester and those who fall into the prediabetes category by hemoglobin A1c level of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation will be approached for consent in our randomized trial.
Once consent is obtained, the subjects will be randomized 1:1 into two parallel groups, the metformin treatment group and the standard of care treatment group (routine prenatal care). A random number generator will allocate the participants to the study groups.
Women taking metformin will continue twice daily dosing for the duration of their pregnancy after randomization. Those in the standard of care group will receive routine prenatal care. Both groups will undergo routine gestational diabetes testing by 28 weeks. Obstetric, maternal, and neonatal outcomes will then be assessed of both groups until the 6 week postpartum visit.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- 240
- Pregnant women with hemoglobin A1c of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation
- Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center
- Patients able to provide written informed consent
- Pre-existing diabetes diagnosis as assessed at visit in the first trimester by history or by laboratory evaluation as listed above
- Presence of contra-indication to metformin (liver, renal, or heart failure) or sensitivity to metformin
- Participants who are under the age of 18
- Multiple Pregnancy
- Patients already taking metformin for other indications
- Fetal defect noted on early dating ultrasound
- Miscarriage before randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin Metformin Study subjects will be randomized to the metformin medication arm. They will take a 500 mg tablet orally twice a day starting at 14 weeks of pregnancy until delivery.
- Primary Outcome Measures
Name Time Method Birth Weight At Birth Used to determine large for gestational age status
- Secondary Outcome Measures
Name Time Method Number of Participants needing Cesarean Section At Delivery Number of Participants with Cesarean Section
Pregnancy Outcome Through study completion, starting at 14 weeks until delivery Number of Participants with Stillbirth, livebirth, pregnancy loss
Neonatal Cooling Within first 2 days of life Need for neonatal cooling within first 48 hours of life
Umbilical Cord Blood Level of Leptin At Birth Placental Pathology At Birth Assessing for malperfusion pathology
Development of Gestational Diabetes Assessed at 28 weeks of pregnancy A glucose tolerance test would be conducted at 28 weeks of pregnancy to diagnose diabetes
Number of Participants with Preterm birth At delivery Less than 37 week delivery
Number of Participants with Neonatal Hypoglycemia Within first 2 days of life Number of Participants requiring Neonatal Intubation At Delivery Apgar Score at Birth At delivery \<6 at 1 and 5 minutes
Umbilical Cord Blood Level of C-peptide At Birth Umbilical Cord Blood Level of Insulin At Birth Number of Participants with Development of Pregnancy Induced Hypertension Through study completion, starting at 14 weeks until delivery Blood pressure, serum laboratory analysis, and urine protein would be assessed for diagnosis
Neonatal Intensive Care Unit Admission At delivery and within first 2 days of life Admission to level 2 or greater neonatal ICU and length of stay
Number of Participants with Neonatal Hyperbilirubinemia Within first 2 days of life Requiring phototherapy
Number of Participants with Postpartum Hemorrhage At Delivery Estimated or quantitative blood loss greater than 1000 mL
Maternal Weight Gain in Pregnancy At enrollment and last prenatal visit, starting at 14 weeks until delivery Number of Participants with Neonatal Birth Trauma At Delivery Brachial plexus injury
Number of Participants with Shoulder Dystocia At Delivery Number of Participants with Neonatal Respiratory Distress At Delivery Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis
Trial Locations
- Locations (1)
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States